Official Title
Low-flow Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform for Correction of Hypercapnia in COVID-19-associated Acute Respiratory Distress Syndrome
Brief Summary

The study aims to investigate the efficacy of extracorporeal CO2 removal for correction of hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distress syndrome

Detailed Description

The prevalence of acute respiratory distress syndrome (ARDS) caused by COVID-19 is
approximately 8%. Lung-protective ventilation is the current standard of care for ARDS. It
limits lung and distal organ impairment, but is associated with hypercapnia in approximately
14% of patients with mild to moderate ARDS and almost all patients with severe ARDS. In this
setting, early implementing of an extracorporeal CO2 removal (ECCO2R) therapy may prevent
further escalation of invasiveness of therapy (eg, need for extracorporeal membrane
oxygenation (ECMO)). A number of low-flow ECCO2R devices are now available and some of those
can be integrated into a renal replacement therapy (RRT) platform. This study aims to
investigate the efficacy of an original ECCO2R system used in conjunction with a RRT platform
in hypercapnic patients with COVID-19-associated mild-to-moderate ARDS with or without acute
kidney injury (AKI) necessitating RRT.

Recruiting
ARDS
Hypercapnic Respiratory Failure
AKI

Device: ECCO2R

ECCO2R integrated into the multiFiltrate device

Eligibility Criteria

Inclusion Criteria:

- mild-to-moderate ARDS according to the Berlin definition

- lung-protective ventilation with positive end-expiratory pressure (PEEP) > 5 cm of
water on mechanical ventilation expected to last > 24 h

- hypercapnia <80 mmHg

- bilateral opacities on chest imaging

Exclusion Criteria:

- age < 18 years

- pregnancy

- patients with decompensated heart failure or acute coronary syndrome

- respiratory acidosis with persistent partial pressure of blood carbon dioxide (PCO2)
levels >80 mmHg

- acute brain injury

- severe liver insufficiency (Child-Pugh scores > 7) or fulminant hepatic failure

- decision to limit therapeutic interventions

- catheter access to femoral vein or jugular vein impossible

- pneumothorax

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Locations

University Hospital Giessen and Marburg, Giessen
Giessen, Hessen, Germany

Contacts

Faeq Husain-Syed, MD
+4964198542351
faeq.husain-syed@innere.med.uni-giessen.de

Istvan Vadasz, MD
+4964198542351
istvan.vadasz@innere.med.uni-giessen.de

Werner Seeger, MD, Study Director
University Hospital Giessen and Marburg, Giessen

University of Giessen
NCT Number
MeSH Terms
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Acute Lung Injury